Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Alexion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Stage V Chronic Kidney Disease

Treatments: Drug: Eculizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01567085

C10-002

2010-019631-35 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants ≥18 years old.

2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.

3. History of prior exposure to HLA (human leukocyte antigen):

   • Prior solid organ or tissue allograft
   • Pregnancy
   • Blood transfusion
   • Prior exposure to specific donor's HLA

Exclusion criteria

1. Has received treatment with eculizumab at any time prior to enrolling in this study.
2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
3. History of severe cardiac disease.
4. Prior splenectomy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Eculizumab

Experimental group

Description:

Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.

Treatment:

Drug: Eculizumab